3. PICO
P Laparotomie (CDC klasse II schoon-besmet)
I Chloorhexidine als pre-operatief antisepticum
C Jodium
O Post-operatieve wondinfectie
N. Pouw , co-assistent M2 VUmc, n.pouw@student.vu.nl
4. PICO
1. Schoon: primair gesloten, niet 2/3/4
2. Schoon-besmet: respiratoir/gastro-intestinaal/urogenitaal
3. Besmet: trauma, inflammatie, niet steriel of GI-lekkage
4. Verontreinigd/geïnfecteerd: oude traumatische wond of
orgaanperforatie met niet-vitaal weefsel
5. PICO
Chloorhexidine:
2% in 70% alcohol
Bindt CH-kation aan negatief geladen celmembraan
Direct optimaal effect
Jodium:
Povidonjodium 10% in water [Betadine]
Oxideert thiol-groep, eiwitstructuur en functie
Optimaal effect na 3min drogen
Huidirritatie met 0,7% sensitisatie
7. Opbrengst zoekstrategie
Noorani et al., (2010) Systematic review and meta-analysis of
preoperative antisepsis with chlorhexidine versus povidone-
iodine in clean-contaminated surgery.
Br J Surg.;97(11):1614-20
Lee et al., (2010) Systematic review and cost analysis
comparing use of chlorhexidine with use of iodine for
preoperative skin antisepsis to prevent surgical site infection.
Infect Control Hosp Epidemiol. ;31(12):1219-29
Totale zoekopbrengst aan einde van powerpoint N. Pouw , co-assistent M2 VUmc, n.pouw@student.vu.nl
8. Opbrengst zoekstrategie
Noorani et al., (2010)
6 studies, n = 5031
Clinical trials, wondinfectie als uitkomst
CDC Klasse II excl. oropharyngeal
Twee reviewers
Oxford quality scoring system (Jadad)
10. Noorani et al., 2010
1. Darouiche et al., (2010) Chlorhexidine–alcohol versus povidone–iodine
for surgical-site antisepsis.
2. Paocharoen et al., (2009) Comparison of surgical wound infection after
preoperative skin preparation with 4 per cent chlorhexidine and
povidone iodine: a prospective randomized trial.
3. Swenson et al., (2009) Effects of preoperative skin preparation on
postoperative wound infection rates: a prospective study of 3 skin
preparation protocols.
4. Culligan et al., (2005) A randomised trial that compared povidone–
iodine and chlorhexidine as antiseptics for vaginal hysterectomy.
5. Berry et al., (1982) A comparison of the use of povidone–iodine and
chlorhexidine in the prophylaxis of postoperative wound infection.
6. Brown et al., (1984): A clinical evaluation of chlorhexidine gluconate
spray as compared with iodophor scrub for preoperative skin
preparation.
11. Noorani et al., 2010
Studie Vergelijking Excl. Uitkomst JADAD
Darouiche
2010
(10%) PVI vs 2% CH in 70% IA <18jr,
Allergie
SSI, sepsis RCT 3
Paocharoen
2009
PVI vs 4% CH SSI RCT 1
Swenson
2009
PVI vs 2% CH vs iodine
povacrylex
SSI Pros 0
Culligan
2005
PVI vs 4% CH CFU RCT 2
Berry
1982
PVI vs 0,5% CH Infectie RCT 0
Brown
1984
PVI scrub vs 0,5% CH spray SSI RCT 2
12. Noorani et al., 2010
Chloorhexidine vermindert het aantal post-operatieve
wondinfecties vergeleken met povidonjodium.
RR 0·68 [95% BI, 0·50 - 0·94]
13. Lee et al., 2010
Lee et al., (2010)
9 studies, totaal aantal patiënten = 3614
RCT’s, wondinfectie en positieve huidkweek als uitkomst
Alle soorten chirurgische ingrepen excl. chlorhexidine
douche, bad of mondspoeling als interventie
Oxford quality scoring system (Jadad)
Kosten-baten analyse
14. Lee et al., 2010
n totaal SSI = 3437
n totaal pos kweek = 827
15. Lee et al., 2010
Chloorhexidine vermindert het aantal post-operatieve
wondinfecties vergeleken met povidonjodium.
RR 0·64 [95% BI, 0·51 - 0·90]
16. Lee et al., 2010
Chloorhexidine vermindert het aantal positieve huidflora-
kweken vergeleken met povidonjodium.
RR 0·44 [95% BI, 0·35 - 0·56]
17. Culligan et al., 2005
n=50
Afname sample vaginale flora pre-desinfectie
Afname sample post-desinfectie
1x na 30min
1x /60min
Kweek positief bij ≥5000 CFU/ml
18. Culligan et al., 2005
Povidonjodium: 17/27 kweken positief (63%)
Chloorhexidine: 5/23 kweken positief (22%)
P = 0·003
19. Bewijskracht
A1
A2
Bewijsniveau in Nederlandse CBO Richtlijnen
Systematische reviews (meta-analyse) die tenminste enkele onderzoeken
van A2-niveau betreffen, waarbij de resultaten van de afzonderlijke
onderzoeken consistent zijn.
Gerandomiseerd vergelijkend klinisch onderzoek van goede kwaliteit van
voldoende omvang en consistentie.
1
Niveau van de conclusie op basis van de literatuuranalyse
Gebaseerd op 1 systematische review (A1) of tenminste 2 onafhankelijk
van elkaar uitgevoerde onderzoeken van niveau A2
20. Critical appraisal
A. Toepasbaarheid Noorani Lee
Past mijn patiënt in de patiëntengroep waarover in het
artikel gerapporteerd wordt?
Ja
Is de interventie die bestudeerd wordt vergelijkbaar
met de interventie die ik wil uitvoeren?
Ja
Is de uitkomst of effectmaat waarover gerapporteerd
wordt van belang voor mijn patiënt?
Ja
21. Critical appraisal
B. Validiteit Noorani Lee
Zijn de studies gerandomiseerd? 5/6 9/9
Was er sprake van geheimhouding voor randomisatie? ? >1/9
Waren de groepen bij start van het onderzoek
vergelijkbaar?
Ja Ja
Is van alle patiënten follow-up beschikbaar Ja Ja
Zijn alle gerandomiseerde patiënten geanalyseerd in
de groep waarvoor ze gerandomiseerd zijn?
Ja Ja
Is de studie goed geblindeerd met betrekking tot:
- Patiënten
- Behandelaars
- Effectbeoordelaars
Ja
Nee
?
Ja
>1/9
>1/9
Aanwijzing voor publication bias bij RCT’s? Nee Nee
22. Conclusie
Het is aangetoond dat bij patiënten die een laparotomie
ondergaan (P), chloorhexidine (I) als pre-operatief
antisepticum werkzamer is dan jodium (C) in het voorkomen
van post-operatieve wondinfecties (O).
Noorani et al., 2010: RR 0·68 [95% BI, 0·50 - 0·94]
Lee et a., 2010: RR 0·64 [95% BI, 0·51 - 0·90]
N. Pouw , co-assistent M2 VUmc, n.pouw@student.vu.nl
23. Discussie
Niet specifiek voor gynaecologische OK’s (andere flora
vaginaal dan dermaal)
Syst. Reviews: Geen onderscheid in oppervlakkig, diep
incisionaal, orgaan en holte
Geen onderscheid in potentiële ernst van positieve
kweken
Therapietrouw (mogelijk ten gunste chloorhexidine)
N. Pouw , co-assistent M2 VUmc, n.pouw@student.vu.nl
26. Darouiche et al., 2010
Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC,
Alsharif A, Berger DH (2010) Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J
Med. 7;362(1):18-26
27. Bewijs uit andere hoek…
Yamamoto N, Kimura H, Misao H, Matsumoto H, Imafuku Y, Watanabe A, Mori H, Yoshida A, Miura S, Abe Y, Toba
M, Suzuki H, Ogawa K, Kanemitsu K. (2014) Efficacy of 1.0% chlorhexidine-gluconate ethanol compared with 10%
povidone-iodine for long-term central venous catheter care in hematology departments: a prospective study.
Am J Infect Control.;42(5):574-6
Method: Each CVC was assigned to either CHG-EtOH 79 vol/vol% or 10% PV-I in accordance with a computer-
generated randomization list. Multiple CVC enrollment in the study by any single patient was permitted during the
study period. For each patient, the CVC insertion site was prepared with CHG-EtOH or PV-I, and allowed to dry for
at least 120 seconds. Specimens were collected by swabbing the CVC exit site skin just before weekly sterile film
dressing change and cleansing with the respective agent. A commercial sterile cotton swab was circled twice
around the CVC exit site and incubated at 35°C overnight on a blood agar plate. Cultured microorganisms were
identified by VITEK 2.
Blood cultures were taken from the patients within 3 hours of the onset of a fever (body temperature ≥38.0°C),
and/or other signs of infection, or inflammation of the CVC exit site. CABSI was diagnosed according to the
definitions of the Centers for Disease Control and Prevention National Healthcare Safety Network.5
28. Bewijs uit andere hoek…
Yamamoto N, Kimura H, Misao H, Matsumoto H, Imafuku Y, Watanabe A, Mori H, Yoshida A, Miura S, Abe Y, Toba
M, Suzuki H, Ogawa K, Kanemitsu K. (2014) Efficacy of 1.0% chlorhexidine-gluconate ethanol compared with 10%
povidone-iodine for long-term central venous catheter care in hematology departments: a prospective study.
Am J Infect Control.;42(5):574-6
1% CGH 10% PI RR= p=
CVC colonisatie 11.9% 29.2% 0·41
[95% BI, 0·18-0·90]
0·030
CABSI totaal 3.4% 14.6% 0·23
[95% BI, 0·06 - 0·93]
0·075
CABSI Incidentie dichtheid /
1000 CVC-dagen
0·21
[95% BI, 0·05-0·88]
0·041
29. Vaginal cleansing with 1% chlorhexidine
Pereira L, Chipato T, Mashu A, Mushangwe V, Rusakaniko S, Bangdiwala SI, Chidede OS, Darmstadt GL, Gwanzura L,
Kandawasvika G, Madzime S, Lumbiganon P, Tolosa JE (2011) Randomized study of vaginal and neonatal cleansing
with 1% chlorhexidine. Int J Gynaecol Obstet.;112(3):234-8.
Objective: To determine the safety, acceptability, and antimicrobial effect of 1% chlorhexidine (CHX) vaginal
washing of women in labor and their neonates.
Methods: Randomized controlled trial of 1% CHX vaginal and neonatal washing compared with no washing (usual
care [UC]). The study included 502 women (334 CHX, 168 UC) who delivered 508 liveborn neonates (335 CHX, 173
UC). Main outcome measures were the incidence of maternal adverse effects, the incidence of neonatal skin rash,
the axillary temparature before and after neonatal wiping, and vaginal culture results.
Results: Maternal demographics did not differ between the groups. No case of maternal rash occured; 4% of
women experienced vaginal burning. An axillary temperature drop of more than 1 °C after CHX cleansing occurred
in 8 neonates; 2 neonates had a minor rash. In the subset of women with positive vaginal cultures as baseline, 1%
CHX eliminated culture growth in 56% after 1 wash, and in 86% after 2 washes.
Conclusions: Use of 1% CHX is safe for neonates, well tolerated by laboring mothers, and effective in treating
vaginal infections during labor. A randomized controlled trial using 1% CHX and powered for a reduction in
neonatal septic mortality is justified based on these data.
30. Vaginal chlorhexidine during labour
Ohlsson A, Shah VS, Stade BC (2014) Vaginal chlorhexidine during labour to prevent early-onset neonatal group B
streptococcal infection. Cochrane Database Syst Rev. doi: 10.1002/14651858.CD003520.pub3.
MAIN RESULTS:
Maternal mild side effects (stinging or local irritation) (three trials, 1066 women) were more commonly
seen in women treated with chlorhexidine (RR 8.50 (95% CI 1.60 to 45.28).
AUTHORS' CONCLUSIONS:
The quality of the four included trials varied as did the risk of bias and the quality of the evidence using
GRADE was very low.
Vaginal chlorhexidine was not associated with reductions in any of the primary outcomes of early-onset
GBS disease (sepsis and/or meningitis) or GBS pneumonia. Vaginal chlorhexidine may reduce GBS
colonization of neonates.
31. Zoekstrategie
("Iodine"[MeSH] OR "iodides"[MeSH Terms] OR "Povidone-
Iodine"[Mesh]) AND ("chlorhexidine"[Mesh] OR
"chlorhexidine gluconate"[Supplementary Concept] OR
"chlorhexidine gluconate, lidocaine drug
combination"[Supplementary Concept] OR
"Hydrex"[Supplementary Concept] OR
"Anticataracticum"[Supplementary Concept]) AND
((Randomized Controlled Trial[ptyp] OR systematic[sb] OR
Review[ptyp]) AND "2005/01/01"[PDat] :
"2015/01/26"[PDat])
Iodine[Title/Abstract] AND Chlorhexidine[Title/Abstract] AND
(systematic[sb] AND "2010/01/01"[PDat] :
"2015/01/26"[PDat])
32. Complete opbrengst zoekstrategie
Noorani A, Rabey N, Walsh SR, Davies RJ (2010) Systematic review and meta-analysis of preoperative antisepsis
with chlorhexidine versus povidone-iodine in clean-contaminated surgery. Br J Surg. 2010 Nov;97(11):1614-20
Lee I, Agarwal RK, Lee BY, Fishman NO, Umscheid CA (2010) Systematic review and cost analysis comparing use of
chlorhexidine with use of iodine for preoperative skin antisepsis to prevent surgical site infection. Infect Control
Hosp Epidemiol. ;31(12):1219-29
Jarral OA, McCormack DJ, Ibrahim S, Shipolini AR (2011) Should surgeons scrub with chlorhexidine or iodine prior
to surgery? Interact Cardiovasc Thorac Surg. ;12(6):1017-21
Hadiati DR, Hakimi M, Nurdiati DS (2014) Skin preparation for preventing infection following caesarean section.
Cochrane Database Syst Rev. 2014 Sep 17;9 [Low-graded evidence]
Dumville JC, McFarlane E, Edwards P, Lipp A, Holmes A. (2013) Preoperative skin antiseptics for preventing surgical
wound infections after clean surgery. Cochrane Database Syst Rev. 28;3
American College of Obstetricians and Gynecologists Women's Health Care Physicians; Committee on Gynecologic
Practice. (2013) Committee Opinion No. 571: Solutions for surgical preparation of the vagina. Obstet Gynecol.
;122(3):718-20.
Scowcroft T. (2012) A critical review of the literature regarding the use of povidone iodine chlorhexidine gluconate
for preoperative surgical skin preparation. J Perioper Pract. ;22(3):95-9. Review. [volledig artikel niet beschikbaar]
33. Overige referenties
Srinivas A, Kaman L, Raj P, Gautam V, Dahiya D, Singh G, Singh R, Medhi B. Comparison of the efficacy of
chlorhexidine gluconate versus povidone iodine as preoperative skin preparation for the prevention of surgical site
infections in clean-contaminated upper abdominal surgeries. Surg Today. 2014 Nov 9
Chaiyakunapruk N, Veenstra DL, Lipsky BA, Saint S (2002) Chlorhexidine compared with povidone-iodine solution
for vascular catheter-site care: a meta-analysis. Ann Intern Med.;136(11):792-801.
CDC/NHSN (2015) Surveillance Definitions for Specific Types of Infections.
http://www.cdc.gov/nhsn/PDFs/pscManual/17pscNosInfDef_current.pdf (accessed 27-01-’15)
34. HICPAC
Centers for Disease Controle and Prevention (1999) Guideline for Prevention
of Surgical Site Infection
Class I/
Clean:
An uninfected operative wound in which no inflammation is encountered and the
respiratory, alimentary, genital, or uninfected urinary tract is not entered. In addition, clean
wounds are primarily closed and, if necessary, drained with closed drainage. Operative
incisional wounds that follow nonpenetrating (blunt) trauma should be included in this
category if they meet the criteria.
Class II/
Clean-Contaminated:
An operative wound in which the respiratory, alimentary, genital, or urinary tracts are
entered under controlled conditions and without unusual contamination. Specifically,
operations involving the biliary tract, appendix, vagina, and oropharynx are included in this
category, provided no evidence of infection or major break in technique is encountered.
Class III/
Contaminated:
Open, fresh, accidental wounds. In addition, operations with major breaks in sterile
technique (e.g., open cardiac massage) or gross spillage from the gastrointestinal tract, and
incisions in which acute, nonpurulent inflammation is encountered are included in this
category.
Class IV/
Dirty-Infected
Old traumatic wounds with retained devitalized tissue and those that involve existing
clinical infection or perforated
viscera. This definition suggests that the organisms causing postoperative infection were
present in the operative field before the operation.
36. Bewijskracht
1 gebaseerd op een systematische review (A1) of ten minste twee
onafhankelijk van elkaar uitgevoerde onderzoeken van niveau A2
2 gebaseerd op ten minste twee onafhankelijk van elkaar uitgevoerde
onderzoeken van niveau B
3 gebaseerd op een onderzoek van niveau A2 of B, of op onderzoek van
niveau C
4 mening van deskundigen, bijvoorbeeld de werkgroepleden
A1 systematische reviews (meta-analyse)
A2 gerandomiseerd vergelijkend onderzoek
B gerandomiseerd vergelijkend onderzoek van matige kwaliteit of
onvoldoende omvang
C niet vergelijkend onderzoek
D mening van deskundigen
Editor's Notes
Toendertijd geloofde men dat vocht in de lucht aanleiding gaf tot wondinfectie. Daarom sloot men open wonden af met (niet-steriele) doeken.
Lister weigerde deze theorie te geloven en na het lezen van het werk van Louis Pasteur, besloot hij de doeken en wonden onder te dompelen in Fenol (Carbolzuur).
Hij publiseerde 2-jaar later zijn resultaten, en dit heeft er deels toe geleid dat artsen in het wit gekleed gaan (om vuil aan te tonen).
Aantal participanten per studie
Bestaan er ook dergelijke tabellen toegespitst op Systematic Reviews???
Bestaan er ook dergelijke tabellen toegespitst op Systematic Reviews???